NCT05669456

Zeit Alert for Stroke at Home (ZASH) Protocol

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Zeit Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, observational, feasibility study to evaluate if the Halo Alert System can be used in the future to detect stroke events in individuals at risk for stroke wearing the Halo Alert System overnight.

Detailed description

This is a single-arm, observational, feasibility study to evaluate if the Halo Alert System can be used in the future to detect stroke events in individuals at risk for stroke wearing the Halo Alert System overnight. The Halo Alert System consists of an EEG sensor headband and is paired with a data transfer device. Approximately 300 subjects with elevated stroke risk will be enrolled and followed for a duration of 90 days. The EEG tracing for each study subject will be labeled after study conclusion with the help of clinically available information on the occurrence of a recurrent stroke. The labeled data will then be used to further develop the existing (operating room based) stroke detection algorithm and adjust the algorithm for outpatient use.

Conditions

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Interventions

Type	Name	Description
DEVICE	Halo Alert System	The Halo Alert System consists of an EEG sensor headband and is paired with a data transfer device.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-06-30
• Completion: 2024-09-30
• First posted: 2022-12-30
• Last updated: 2022-12-30